Overview

This trial has been completed.

Condition anemia
Sponsor Hoffmann-La Roche
Start date July 2013
End date September 2016
Trial size 437 participants
Trial identifier NCT01902628, ML28261

Summary

This prospective observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients not on dialysis with renal anemia. Patients initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice will be followed for 10 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Proportion of patients with hemoglobin (Hb) levels within 10.0 - 12.0 g/dL in Months 8-10
time frame: 10 months

Secondary Outcomes

Measure
Incidence of dose adjustments
time frame: 10 months
Quality of life: Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire
time frame: 10 months
Safety: Incidence of adverse events
time frame: 10 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Patients with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4) - Initiated on Mircera treatment (patients may have received Mircera treatment for up to 3 months before study enrollment) - Life expectancy > 10 months Exclusion Criteria: - Malignant disease - Significant or acute bleeding - Poorly controlled hypertension - Blood transfusion during the previous 2 months - Hypersensitivity to Mircera or any of its excipients

Additional Information

Official title An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-dialysis Chronic Kidney Disease Subjects With Renal Anaemia, Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta) (OPTIMA).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.